ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.
ISO 9626:2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.
It provides requirements and test methods for the tubes manufactured for needles as component used in medical devices. Additional performance testing on the tube aspect may be required when the component is incorporated in the ready-to-use device.
It specifies the dimensions and mechanical properties of steel tubing of designated metric sizes 3,4 mm (10 Gauge) to 0,18 mm (34 Gauge).
It does not apply to flexible stainless steel tubing because the mechanical properties differ from those specified for rigid tubing in ISO 9626:2016. However, manufacturers and purchasers of flexible tubing are encouraged to adopt the dimensional specifications given in ISO 9626:2016.
Le présent document apporte des modifications à la norme de base en : - ajoutant des spécifications applicables aux tubes à paroi normale et à paroi mince - ajoutant des diamètres intérieurs minimaux pour les tubes à paroi mince - révisant le diamètre extérieur maximal des tubes de dimension théorique 0,6 mm - supprimant le diamètre intérieur maximal de tous les types de tubes - révisant les moyens permettant de spécifier les aciers à utiliser.
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